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Emergency COVID-19 exemptions end for ventilators and personal protective equipment

29 January 2021

Two emergency exemptions that were made to facilitate the supply of ventilators and personal protective equipment in Australia during the COVID-19 emergency will cease on 31 January 2021. After this date, the medical devices previously supplied under the exemptions can no longer continue to be supplied, and will need to be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia.

The first exemption, the Therapeutic Goods (Medical Devices—Ventilators) (COVID-19 Emergency) Exemption 2020 (the ventilator exemption), commenced on 8 April 2020. The ventilator exemption enabled ventilators manufactured in Australia to minimum technical requirements to be supplied to hospitals in Australia without meeting certain requirements under the Therapeutic Goods Act 1989 (the Act). Ventilators supplied to hospitals under the ventilator exemption are not TGA approved.

The ventilator exemption was made to support the Australian Government's rapid response to the COVID-19 emergency by facilitating access to medical devices to treat patients requiring invasive ventilation. The ventilator exemption ceases on 31 January 2021, after which ventilators manufactured under the exemption are no longer permitted to be supplied to Australian hospitals.

While hospitals may continue to use ventilators acquired under the ventilator exemption, it is the responsibility of hospital management to consider how and where to use these ventilators, considering their limitations.

Principally, only ventilators that have been included in the ARTG are permitted to be supplied in Australia, in accordance with the Act and the Therapeutic Goods (Medical Devices) Regulations 2002). Manufacturers should also follow guidance for manufacturing medical devices for COVID-19.

For more information regarding the Therapeutic Goods (Medical Devices—Ventilators) (COVID-19 Emergency) Exemption 2020, see Exemption to enable the domestic manufacture and supply of ventilators.

The second exemption, the Therapeutic Goods (Medical Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 (the face masks and other articles exemption), was made on 22 March 2020 to support the purchase of certain kinds of medical devices by the Australian Government Department of Health for the National Medical Stockpile. This exemption supported the Australian Government's rapid COVID-19 response by facilitating access to certain kinds of medical devices intended to assist in reducing the transmission of infection between individuals, particularly patients and health care professionals. The face masks and other articles exemption also ceases on 31 January 2021.

For information regarding the regulation of faces masks and other types of personal protective equipment, see Face masks and COVID-19.

Please contact the TGA at devices@health.gov.au for more information.